Sie sind auf Seite 1von 17

Research Report

A Comparison of Five Low Back


Disability Questionnaires: Reliability
and Responsiveness

APTA is a sponsor of the


Decade, an international,
multidisciplinary initiative
to improve health-related
quality of life for people with
musculoskeletal disorders.

Background and Purpose. The aim of this study was to examine 5 commonly
used questionnaires for assessing disability in people with low back pain. The
modified Oswestry Disability Questionnaire, the Quebec Back Pain Disability
Scale, the Roland-Morris Disability Questionnaire, the Waddell Disability
Index, and the physical health scales of the Medical Outcomes Study 36-Item
Short-Form Health Survey (SF-36) were compared in patients undergoing
physical therapy for low back pain. Subjects and Methods. Patients with low
back pain completed the questionnaires during initial consultation with a
physical therapist and again 6 weeks later (n106). Test-retest reliability was
examined for a group of 47 subjects who were classified as unchanged and
a subgroup of 16 subjects who were self-rated as about the same. Responsiveness was compared using standardized response means, receiver operating
characteristic curves, and the proportions of subjects who changed by at least
as much as the minimum detectable change (MDC) (90% confidence interval
[CI] of the standard error for repeated measures). Scale width was judged as
adequate if no more than 15% of the subjects had initial scores at the upper
or lower end of the scale that were insufficient to allow change to be reliably
detected. Results. Intraclass correlation coefficients (2,1) calculated to measure reliability for the subjects who were classified as unchanged and those
who were self-rated as about the same were greater than .80 for the Oswestry
and Quebec questionnaires and the SF-36 Physical Functioning scale and less
than .80 for the Waddell and Roland-Morris questionnaires and the SF-36
Role LimitationsPhysical and Bodily Pain scales. None of the scales were
more responsive than any other. Discussion and Conclusion. Measurements
obtained with the modified Oswestry Disability Questionnaire, the SF-36
Physical Functioning scale, and the Quebec Back Pain Disability Scale were
the most reliable and had sufficient width scale to reliably detect improvement
or worsening in most subjects. The reliability of measurements obtained
with the Waddell Disability Index was moderate, but the scale appeared to
be insufficient to recommend it for clinical application. The RolandMorris Disability Questionnaire and the Role LimitationsPhysical and
Bodily Pain scales of the SF-36 appeared to lack sufficient reliability and
scale width for clinical application. [Davidson M, Keating JL. A comparison
of five low back disability questionnaires: reliability and responsiveness.
Phys Ther. 2002;82:8 24.]

Key Words: Disability, Low back pain, Measurement, Questionnaire.

Megan Davidson, Jennifer L Keating

Physical Therapy . Volume 82 . Number 1 . January 2002

he restoration of normal function is considered


a key outcome of physical therapy for low back
problems.1,2 Physical therapists, therefore, need
measurement tools that accurately assess function and monitor change over time. Activity limitations
are defined in the World Health Organizations International Classification of Functioning, Disability and Health
[ICIDH-2] as difficulties an individual may have in
executing activities.3 Impairments such as decreased
range of movement and reduced straight leg raise can be
observed by therapists. However, direct observation of
activity limitation is impractical, and physical therapists
often rely on clients self-report to assess the impact of
low back pain on daily activities. Physical therapists
routinely collect information on activity limitations in
the course of their assessments, but the data may not
always be collected in a standardized format that yields a
measurement with known reliability and validity.4,5 Standardized self-report questionnaires provide a convenient
method of collecting and synthesizing a large amount of
information on activity limitation.1,2
Many questionnaires have been developed to measure
activity limitations in people with low back pain, but
there is little evidence that physical therapists routinely
use these tools. One of the barriers to their widespread
clinical use is the proliferation of similar questionnaires.1,6,7 A search of MEDLINE and CINAHL databases, the reference lists of retrieved articles, and published compilations of outcome measures located 24 low

back region-specific questionnaires. There are also a


number of generic health status measures available.
Region-specific questionnaires for low back pain are
thought to have the advantage of containing only items
that are relevant to people with low back problems,
whereas generic tools can be used across a wide range of
conditions.
In the study reported in this article, we judged a questionnaire as having potential clinical utility if it could be
self-administered, was brief and easy to complete, was
simple to score, and had not been shown to have serious
floor or ceiling effects in a general ambulatory clinical
population. We also wanted the questionnaire to have
adequate content validity (ie, relevant ICIDH-2 categories were represented) and evidence of credible construct validity and good reliability. Five questionnaires
met these criteria: the modified Oswestry Disability
Questionnaire,8,9 the Quebec Back Pain Disability
Scale,10 the Roland-Morris Disability Questionnaire,11
the Waddell Disability Index,12 and the physical health
scales of the Medical Outcomes Study 36-Item ShortForm Health Survey (SF-36).13,14 We limited the study to
5 questionnaires because we estimated that the questionnaires would take up to 30 minutes to complete and we
felt this was the most we could expect from respondents.
The SF-36 questionnaire was chosen because it is relatively brief compared with other generic questionnaires
and normative data are available in many countries.15,16
In addition, we believe that if a generic questionnaire

M Davidson, PT, BAppSc, is Lecturer, School of Physiotherapy, La Trobe University, Bundoora, 3053, Melbourne, Australia
(M.Davidson@latrobe.edu.au). Address all correspondence to Ms Davidson.
JL Keating, PT, PhD, is Lecturer, School of Physiotherapy, La Trobe University.
Ms Davidson provided concept/research design, writing, data collection and analysis, and project management. Dr Keating provided consultation
(including review of manuscript before submission).
This study was approved by the Human Ethics Committee of La Trobe University.
This article was submitted October 18, 2000, and was accepted June 15, 2001.

Physical Therapy . Volume 82 . Number 1 . January 2002

Davidson and Keating . 9

can be shown to perform as well as a condition-specific


questionnaire, then it becomes redundant to use both
condition-specific and generic questionnaires. The
selected questionnaires have also been identified by
other authors1,2,10,1719 as suitable for use in physical
therapist practice. Scores have been shown to be correlated with related variables such as pain intensity and
physical impairments and have also been demonstrated
to detect change in functioning over time.10,18,20 22
It is important that the measurement properties of
questionnaires are derived from or confirmed on samples from the population on whom the measurements
will be used in clinical practice.14,23 This is particularly
the case for studies of reliability and responsiveness
because the results of these studies provide the information required for interpreting the scores of individuals.
Client groups receiving the services of other health care
professionals (eg, orthopedic surgeons) are unlikely to
be representative of the population receiving physical
therapy. Much of the information currently available on
the reliability of measurements obtained with and
responsiveness of the 5 questionnaires is from studies
that drew samples from clinical populations other than
patients receiving physical therapy,8,9,11,12,14,24 from only
1 or 2 physical therapy practices or hospital departments,17,18,25 or from both physical therapy and medical
treatment centers.10
Little information is currently available on the reliability
of measurements obtained with and responsiveness of
the Quebec and Waddell questionnaires, and no studies
have demonstrated the reliability of measurements
obtained with and responsiveness of these 5 questionnaires when concurrently administered to clients receiving treatment from physical therapists in a range of
clinical settings. The aim of this study, therefore, was to
compare the reliability of measurements obtained with
and responsiveness of the modified Oswestry, Quebec,
Roland-Morris, and Waddell questionnaires and the
SF-36 physical health scales in an ambulatory clinical
population seeking physical therapy for low back pain in
hospital outpatient departments, community clinics, and
private practices.
High test-retest reliability coefficients have generally
been reported for the scores obtained with the 5 questionnaires. For the original Oswestry questionnaire, values of r .99 over 24 hours8 and ICC.94 over 1 to 14
days10 are typical. Baker et al9 reported a reliability
coefficient of r .89 for a same-day test-retest of the
modified Oswestry questionnaire. Kopec and colleagues10 reported the test-retest reliability for measurements obtained with the Quebec scale as ICC (2,1).93
over 1 to 14 days. For the Roland-Morris questionnaire,
reported reliability estimates ranged from .91 for same-

10 . Davidson and Keating

day administration,11 ICC.93 for 1 to 14 days,10 and


ICC.86 over 3 to 6 weeks.25 No test-retest reliability
studies have been reported for the Waddell index,
although one research group12 reported interrater reliability (kappa .60) for each of the 9 questions administered by interview. For the Physical Functioning scale
of the SF-36, Kopec and colleagues10 reported an
ICC.73 over 1 to 14 days. Patrick et al22 reported ICCs
of .89, .89, and .67 for the SF-36 Physical Functioning,
Role LimitationsPhysical, and Bodily Pain scales,
respectively, over a period of 3 months. In those studies
where test-retest reliability was evaluated over longer
periods, only data from subjects who were classified as
unchanged based on patient ratings10,22 or patient and
therapist ratings on a retrospective change scale25 were
included.
The reliability coefficient reported as a value between 0
and 1 does not allow us, in our view, to judge whether
the measurement has sufficient reliability for a particular
purpose. To examine the effects of intervention, a
therapist needs to know when change in an observed
score indicates that real change has occurred. This is
called the minimum detectable change (MDC) and
has been defined by Stratford et al17 as the amount of
change required to be 90% confident that an observed
change in scores reflects real change in the underlying
variable. Stratford and colleagues17,25 have reported the
MDC for the Roland-Morris questionnaire as 4 to 5
points. No authors have reported the MDC for the
modified Oswestry, Quebec, and Waddell questionnaires
or the SF-36 physical health scales.
No improvement can be detected for an individual who
has the best possible score prior to treatment, and no
worsening can be detected for an individual who has the
worst possible score on a particular scale. The lowest and
highest possible scores are called the floor and ceiling of the scale. McHorney and Tarlov26 suggested that
health surveys with more than 15% of respondents
scoring the lowest or highest possible score initially
should not be used. However, because we believe an
observed change in scores must be at least equal to the
MDC to be 90% confident that the observed change is
not simply due to measurement error, we propose that
questionnaires with more than 15% of respondents
scoring within the MDC at the upper or lower end of the
available range of scores should not be used. For example, we believe that if a questionnaire has a possible
range in scores from 0 to 100 and an MDC of 15 points,
then no more than 15% of subjects should score less
than 15 or more than 85. In this way, the MDC can be
useful not only for interpreting change in questionnaire
scores but also for providing a benchmark for choosing
a measurement tool that is practical for use with a
particular clinical population. In this article, we use the

Physical Therapy . Volume 82 . Number 1 . January 2002

term scale width to indicate the capacity of a scale to


have initial scores that are far enough onto the scale to
allow detection of change in scores over time.
Responsiveness refers to the ability of a measurement tool
to detect meaningful change over time and is also called
sensitivity to change.23 Many methods have been proposed to explore the responsiveness of questionnaires,27
and all involve the administration of the questionnaire
before and after a period of time (usually when the
participants are receiving treatment) during which it is
expected that function will improve. Methods of exploring responsiveness can be classified either as those that
measure change alone (distribution-based methods) or
those that measure clinically meaningful change
(criterion-based methods).27,28 Criterion-based methods
require that a judgment be made as to whether
clinically meaningful change has occurred over the
retest period. This is often achieved by having the
participants rate the overall amount of change they
have experienced.10,20,21,25
In 3 studies,10,20,21 various combinations of questionnaires were administered to people who were receiving
physical therapy, and the questionnaires responsiveness
was studied. The Oswestry and Roland-Morris questionnaires were compared by Stratford et al21 in Ontario,
Canada, and by Beurskens et al20 in the Netherlands.
Kopec et al10 in Quebec, Canada, examined reliability of
measurements from and responsiveness of the Oswestry,
Quebec, and Roland-Morris questionnaires and the
SF-36 Physical Functioning scale, but only 65% of the
subjects were seen by physical therapists. In all 3 studies,
the questionnaires were administered on 2 occasions,
and a global change scale was used as the criterion for
meaningful change. Direct comparison of these 3 studies
is hampered by differences in subject characteristics, the
use of different retest periods, differing interventions
and global change scales, and the variety of strategies for
classifying subjects as changed or unchanged.
Of these 3 studies, only Stratford and colleagues21 tested
whether there were differences in observed responsiveness between the questionnaires used in the study. The
conclusions of the other groups of authors were based
only on the rank order of the magnitude of the particular responsiveness index used. However, without statistical testing of the difference between questionnaires, it
is not clear whether observed differences are likely to
reflect genuine or chance variations.27
Method
This was a prospective, multi-site study with repeated
measurements taken when subjects entered the study
and 6 weeks later. Over a 5-month period, consecutive
eligible patients were invited by their treating therapist

Physical Therapy . Volume 82 . Number 1 . January 2002

to participate in the study. Patients were eligible if they


were aged 18 years or older, were able to read and write
English, were seeking treatment for a complaint of low
back pain, and provided written informed consent. We
defined low back pain as pain in the lumbar region with
or without referral of pain to the lower extremities.
Subjects were recruited from the physical therapy outpatient departments of 3 hospitals, 3 community health
services, and 4 private physical therapy practices. The 10
health care agencies from which the subjects came
represented, in our view, the range of settings where
physical therapy services are delivered to patients with
low back pain who were ambulatory and were located in
urban areas of high, middle, and low socioeconomic
status.
Subjects who consented to participate in the study were
given a package of questionnaires at the recruitment
site, with a reply paid envelope for returning the questionnaires by mail. After 6 weeks, a second set of
questionnaires was sent by mail to the subjects. On both
occasions, questionnaires were presented in random
order as determined by a random numbers table. The
battery of questionnaires were bundled together with a
paper clip. The forms were scan-forms and therefore
could not be stapled. Because completion of questionnaires was unsupervised, there was no way of knowing
whether subjects completed the questionnaires in the
order in which they were presented. A reminder was
mailed if the second set of questionnaires was not
returned within 10 days. A 6-week retest interval was
chosen for both the reliability and responsiveness studies. We agree with other authors22,25 who contend that
the variability in scores over a typical clinical retest
period is more likely to reflect true variability in scores
than that found with very short retest periods. We
believe that 6 weeks is commonly used in practice as a
time for comprehensive reassessment of patients with
low back pain, particularly if they have not resumed their
normal activities.29,30 The type and frequency of treatments applied to patients in this study were not under
investigation. Subjects were recruited at the first or
second consultation for their current episode of back
pain, and the combination of treatment and the natural
history of the condition constituted the construct for
change.11,27 We anticipated, based on the results
reported by van den Hoogen et al,31 that many subjects
would experience some improvement over a 6-week
period.
Materials
We administered by mail 5 questionnaires that we
believed were most likely to be useful in clinical practice.
The modified version of the Oswestry Disability Questionnaire9 does not include a reference to medications
in the pain and sleeping sections and is therefore, in our

Davidson and Keating . 11

Table 1.
Characteristics of the Oswestry Disability Questionnaire,8,9 Quebec Back Pain Disability Scale,10 Roland-Morris Disability Questionnaire,11
Waddell Disability Index,12 and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Functioning, Role
LimitationsPhysical, and Bodily Pain Scales13,14

Questionnaire

Reference Perioda

No. of
Items
in Scale

No. of
Response
Options

Score
Range

Better Function
Indicated by

Oswestry Disability Questionnaire

Not specified

10

0100

Lower scores

Quebec Back Pain Disability Scale

Today

20

0100

Lower scores

Roland-Morris Disability Questionnaire

Today

24

024

Lower scores

Waddell Disability Index

Since onset of back pain

09

Lower scores

SF-36 Physical Functioning scale

Now

10

0100

Higher scores

SF-36 Role LimitationsPhysical scale

Past 4 wk

0100

Higher scores

SF-36 Bodily Pain scale

Past 4 wk

5 and 6

0100

Higher scores

Activity limitations experienced during this period or at this point in time.

view, more widely applicable, as not all patients will be


taking medications. We used the original Roland-Morris
Disability Questionnaire,11 the final format of the Quebec Back Pain Disability Scale recommended by the
developers,10 the Waddell Disability Index wording from
Delitto,2 and the Australian version of the SF-36.32
Characteristics of the 5 questionnaires are shown in
Table 1. The Oswestry, Quebec, Roland-Morris, and
Waddell questionnaires were all developed to measure
activity limitation in people with low back problems and
take only a few minutes to complete and score. Scores
for the individual questions are summed to provide a
single index score for each questionnaire, and higher
scores indicate greater activity limitation. In contrast, the
SF-36 is a generic health survey that is designed to assess
health for any population and for any condition.1315
The SF-36 consists of 8 scales that provide a profile of
scores, with higher scores indicating better health status.
The 10-item Physical Functioning scale is used to measure activity limitations and so, to a lesser extent, does
the 4-item Role LimitationsPhysical scale and the 2-item
Bodily Pain scale. The SF-36 takes about 10 minutes to
complete, and a scoring algorithm is used to calculate
scores.32
Questionnaire scores were calculated according to developers instructions. For the Oswestry questionnaire, the
sum of the section scores was divided by the total
possible score (50 if all sections are completed), and the
resulting total was multiplied by 100 to yield a percentage score. The Quebec questionnaire total score was
calculated by summing the 20 individual item scores.
The Roland-Morris questionnaire score was a count of
the chosen items, and the Waddell questionnaire score
was the sum of the yes responses. The scoring methods
prescribed by the test developers were applied to the
SF-36 Physical Functioning, Role LimitationsPhysical,
and Bodily Pain scales.32
12 . Davidson and Keating

In addition to the 5 questionnaires, demographic data


and details of current and past medical history were also
collected initially using the questionnaire designed for
this study. At follow-up, a 7-level global change scale was
included with the questionnaires. This scale asked subjects to rate the extent to which their back problem had
changed over the past 6 weeks. The rating scale, previously used in a study by Patrick and colleagues,22 had 7
response options: 1completely gone, 2much better, 3better, 4a little better, 5about the same,
6a little worse, and 7much worse. Many scales
have been used to rate global change, from a simple
3-level better/the same/worse scale10 to a 15-level
scale with 7 levels of improvement and worsening.10,17,21
We decided to steer what we considered a middle course
between a very parsimonious scale that lacked any distinction in the magnitude of change and a complex scale
that subjects may have found difficult to interpret and
complete without assistance. The selected rating scale
had 4 levels for rating improvement but only 2 ratings of
worsening. We believe this rating scale was appropriate for rating overall change for 2 reasons. First, there
is no opposite of completely gone, yet complete
resolution of the problem is the optimal patient
outcome. Second, we expected that few subjects would
report a worsening of their problem, and therefore an
additional step between a little worse and much
worse was unnecessary.
Data Analysis
Unless otherwise stated, statistical analyses were performed using SPSS for Macintosh Version 6.1.* Testretest reliability was explored for a subgroup of patients
who were identified post hoc as not changed by what we
believed to be a clinically meaningful amount over the

* SPSS Inc, 444 N Michigan Ave, Chicago, IL 60611.

Physical Therapy . Volume 82 . Number 1 . January 2002

6-week retest period. That is, we classified subjects who


self-reported their condition as about the same or only
a little better or a little worse as unchanged. A
paired t test was also used to test the hypothesis that the
questionnaire scores for the unchanged group at the 2
administrations were not different (P.05). Based on
our experience and that of other authors,20,25 we believe
that patients who report only a little change are unlikely
to have experienced clinically meaningful change, which
we defined as the smallest change in the domain of
interest that can be considered significant. To check the
validity of this assumption, we used a paired t test to
check that scores for the subgroup who reported they
were a little better were not different between the start
of the study and follow-up.
Intraclass correlation coefficients (2,1)33 were then calculated for each of the questionnaires. We used parametric tests because, with the exception of the SF-36
Role LimitationsPhysical scale, the data were normally
distributed or approached a normal distribution, and
pretest and posttest variances were equivalent. The SF-36
Role LimitationsPhysical scale scores were positively
skewed at pretest and posttest for the unchanged
group. It has been demonstrated, however, that even
severely abnormal distributions have little effect on the
result of the t test or the F test when the samples come
from the same population, and violation of the homogeneity of variance assumption has little effect on the
result provided the sample sizes are the same.34 To check
the validity of measurements obtained with our post hoc
method of identifying a stable group of subjects, we
calculated ICCs for another group of subjects, those with
back pain of more than 6 months duration, who a priori
could be expected to experience little change over a
6-week retest period.
We defined the minimum detectable change as the 90% CI
of the error associated with the repeated measurements.17 First, the standard error of measurement
(SEM) was determined by the formula:
(1)

SEMSDav (1R)

where SDav was the average standard deviation of the


scores initially and at follow-up for the 106 subjects who
completed both sets of questionnaires and R was the
test-retest reliability coefficient for the 47 subjects classified as unchanged.35 The error associated with the
repeated measurements was calculated by the formula:
(2)

SEMrepeat 2SEM

and this step recognizes that there is error associated


with both the first and second measurements.36 The 90%
CI (the MDC) was calculated by multiplying the result by

Physical Therapy . Volume 82 . Number 1 . January 2002

1.64 (the tabled z value). This calculation can be interpreted as the magnitude of change, expressed in scale
points, required to be 90% confident that the observed
change reflects real change and not just measurement
error.17
Unless subjects score far enough onto the scale to allow
change by at least as much as the MDC, there is
insufficient scale width to reliably detect change over
time. To evaluate scale width, we calculated for each
questionnaire the proportion of the 140 subjects who
returned the initial questionnaire who did not register
an initial score that would allow at least that amount of
improvement or worsening to be registered at follow-up.
Responsiveness was quantified in 3 ways. We used one
distribution-based method (standardized response
means [SRMs]), one criterion-based method (receiver
operating characteristic [ROC] curves), and a method
that counted the proportion of subjects who changed by
at least as much as the MDC. The SRM was calculated by
dividing the mean change by the standard deviation of
change scores.10,20,27,37 We chose the SRM because a
method of testing the significance of observed differences in SRMs has been described by Liang et al.37
Confidence intervals were constructed using the jackknife method detailed by Liang et al,37 and a paired t
test was used to compare the estimated population SRMs
derived by this method.27,37 Rather than compare the
SRMs for questionnaires using every possible pair-wise
comparison, we limited the number of comparisons by
comparing the highest and lowest SRMs until nonsignificant comparisons occurred.
Criterion-based methods of evaluating responsiveness
require that a judgment be made as to whether clinically
meaningful change has or has not occurred.27,28 In this
study, subjects were classified as having improved by an
important amount if they rated their back problem as
completely gone, much better, or better at posttest
and as unchanged if they reported being a little
better, about the same, or a little worse. Receiver
operating characteristic curve analysis was performed
using Accuroc Version 2.0. The area under the ROC
curve reflects the ability of the test to discriminate
between subjects who have improved from subjects who
are unchanged.23,27 A value of 1 for the area under the
curve represents perfect (100%) accuracy, whereas a
value of .50 represents chance alone. Accuroc uses a
chi-square statistic to compare ROC curves for different
questionnaires. Even without the Bonferroni adjustments for the multiple post hoc comparisons, there were
no observed differences in area under the ROC curves
among the different instruments. The 95% CIs of the

Accumetric Corp, 1650 Cedar Ave, Montreal, Quebec, Canada H3G 1A4.

Davidson and Keating . 13

14 . Davidson and Keating

SF-36Medical Outcomes Study 36-Item Short-Form Health


Positive scores reflect improvement, except for the SF-36 for which negative scores indicate improvement. All scales scored 0 100, except
Roland-Morris Disability Questionnaire (0 24) and Waddell Disability Index (0 9).

15
10
18
13
11
7.5
2
1
2
2
18
17
4
Much worse (n2)

Survey.13,14

11
0.3

About the same (n16)

A little worse (n3)

14

11
2

11
13

3
A little better (n28)

10

9
Better (n20)

25

25
16

30

19
16
Much better (n26)

38
33
Completely gone (n6)

17

21
4

5
28

29
17

1.6
10

13
7

5
1.6

0
7

7
1

5
3

6
7

26

22
12

14
47

41
6

26
25

13

15

2.5
1.6

2
1

27

26
46

31
48

38

19

42

32

16
3
2

38

58

SD
X
SD
X
SD
X
SD
X
SD
X
X

Global Change
Scale

Self-Rated Change in Questionnaire Scores (n101)a

Questionnaire scores obtained when the study began


and at follow-up for the unchanged and improved
groups are shown in Table 4. For the unchanged

Table 2.

The mean change in scores for subjects in each of the 7


levels of the global change scale is shown in Table 2 for
the 101 subjects who completed both sets of questionnaires and the global change scale. We classified the 47
subjects who reported that their back problem was
about the same, a little better, or a little worse as
unchanged and the 52 subjects who reported that their
back problem was better, much better, or completely gone as improved. Sample characteristics for the
unchanged and improved groups are shown in Table
3. The mean age of the unchanged group was 55 years
(SD17, range19 83), and the mean age of the
improved group was 49 years (SD16, range20 80)
(t(97)1.87, P.06).

RolandMorris
Disability
Questionnaire11

Results
Of 284 patients with a complaint of low back pain, 226
met the eligibility criteria to participate in the study, and
207 (92%) agreed to participate. One hundred forty
participants (68%) returned the first set of questionnaires, and 106 participants (51%) returned the
follow-up package 6 weeks later. Five subjects who completed both sets of questionnaires failed to complete the
global change scale. The time taken to return the
questionnaires at both pretest and posttest was a median
of 8 days. There was no difference in age or sex between
subjects who returned both sets of questionnaires and
those who returned only the first set.

Waddell
Disability
Index12

where p is the observed proportion and n is the number


of subjects. The observed proportion 1.96 SEp yields
the 95% CI.39 The Cochran Q test was used to determine
whether the proportions were different among all of the
questionnaires.

SD

p1p
n

SF-36
Physical
Functioning
Scale

Quebec
Back Pain
Disability
Scale10

SEp

Oswestry
Disability
Questionnaire8,9

(3)

SF-36 Role
Limitations
Physical Scale

The third method of evaluating responsiveness relates


responsiveness to reliability and has not previously been
used to compare concurrently administered questionnaires. Goldie and colleagues38 suggested that the proportion of subjects who improve by at least as much as
the MDC could be used as an indicator of test responsiveness. We have termed this a reliable-change
approach. We calculated the proportion of subjects who
registered a change in questionnaire scores equal to or
greater than the MDC. The standard error of the proportions (SEp) was calculated as:

SD

SF-36 Bodily
Pain Scale

areas under the ROC curves show the similarities among


questionnaires.

Physical Therapy . Volume 82 . Number 1 . January 2002


Table 3.
Sample Characteristics of Unchanged and Improved Groups
Unchanged
(n47)

Improved
(n52)

Variable

No.

No.

Age (y)
1830
3140
4150
5160
6170
71

4
6
14
4
9
10

8.5
12.8
29.8
8.5
19.1
21.3

6
12
10
11
5
8

11.5
23.1
19.2
21.2
9.6
15.4

Sex
Male
Female

17
30

36.2
63.8

14
38

26.9
73.1

Work situation
Employed
Unemployed
Not in the labor force

14
5
28

29.8
10.6
59.6

24
3
25

46.1
5.8
48.1

Receiving compensation
Yes
No

2
45

4.3
95.7

7
45

13.5
86.5

Duration of current episode


1 wk
2
16 wk
10
6 wk to 6 mo
11
6 mo
24
Missing

4.2
21.3
23.4
51.1

9
22
10
9
2

17.3
42.2
19.2
17.3
4.0

8
20
19

17.0
42.6
40.4

20
20
12

38.5
38.5
23.0

3
9
22
13

6.4
19.2
46.8
27.6

5
20
21
5
1

9.6
38.5
40.4
9.6
1.9

Pain location
Back only
Buttock, groin, or thigh
Below knee
Previous episodes
None
15
5
Continuous pain
Missing

group, normal distribution of scores when the study


began and at follow-up was confirmed by the K-S Lilliefors test for the Oswestry and Quebec questionnaires
and the SF-36 Physical Functioning scale initially and at
follow-up and for the SF-36 Bodily Pain scale initially.
The K-S Lilliefors test is the Kolmogorov-Smirnov statistic with a Lilliefors significance level for testing normality.40 Data are normally distributed if the significance
level is greater than .05. The K-S Lilliefors test is very
sensitive to departures from normal distribution, so a
visual inspection was also made of histograms and box
plots of the data that did not meet the K-S Lilliefors
standard.40 Only the SF-36 Role LimitationsPhysical
scale data were extremely positively skewed, reflecting a
large floor effect, with 68% of the subjects scoring the
lowest (worst) possible score initially and 25% of the
subjects scoring the lowest (worst) possible score at
follow-up.

Physical Therapy . Volume 82 . Number 1 . January 2002

Table 4 shows that for the 47 subjects who were classified


as unchanged, there was no difference between initial
and follow-up scores on any questionnaire except the
SF-36 Bodily Pain scale. Scores on this scale improved by
an average 8 points (SD20) over the retest period
(t(46)2.88, P.006). For the 52 subjects classified as
improved, all questionnaire scores were different at
follow-up (P .0001). Because the SF-36 Bodily Pain
scale scores initially and at follow-up for the group
classified as unchanged were different, we examined
the subgroup of 28 subjects who said their problem was
a little better. The SF-36 Bodily Pain scale scores
improved by an average of 12 points (SD22) over the
retest period (t(27)2.97, P.006), but there were no
differences between initial and follow-up scores for any
of the other questionnaires. Because the SF-36 Bodily
Pain scale score indicated that the subjects who rated
themselves as a little better had changed, we calculated
the ICC (2,1), SEM, SEMrepeat, and MDC for the subjects
classified as unchanged and for the subgroup of 16
subjects who rated their problem as about the same at
follow-up (Tab. 5). Scores initially and at follow-up for
the 16 subjects were confirmed by the KS-Lilliefors test
to be normally distributed, except for the SF-36 Role
LimitationsPhysical scale scores, which were positively
skewed. Paired t tests confirmed that for all scales, the
questionnaire scores were not different between the start
of the study and follow-up.
The ICCs exceeded .80 for the Oswestry and Quebec
questionnaires and the SF-36 Physical Functioning scale
for the unchanged group of 47 subjects, and the ICCs
for these questionnaires were higher than for the RolandMorris questionnaire or the SF-36 Role Limitations
Physical or Bodily Pain scale (there was no overlap of
95% CIs for the reliability coefficients). The 95% CI for
the Waddell questionnaire overlaps with those of all the
other scales. Reliability coefficients for a group of 37
subjects with back pain of more than 6 months duration
were similar or identical to the coefficients for the group
that was classified as unchanged.
For the subgroup of 16 subjects who rated themselves as
about the same, the reliability coefficient for the
Oswestry questionnaire was higher, based on the 95%
CIs, than that obtained for the Roland-Morris questionnaire and the SF-36 Role LimitationsPhysical scale. The
reliability coefficient for the SF-36 Physical Functioning
scale was higher than that obtained for the RolandMorris questionnaire. The 95% CIs of the Roland-Morris
questionnaire and the SF-36 Role LimitationsPhysical
and Bodily Pain scales were very wide (Tab. 5).
Scale width was calculated on the 140 subjects who
completed initial questionnaires and is shown in Table 6
for the MDC calculated for the unchanged group and

Davidson and Keating . 15

Table 4.

Questionnaire Initial and Follow-up Scores for Subjects Classified as Unchanged and Improveda
Subjects Classified as
Unchanged (n47)
Initial

Subjects Classified as
Improved (n52)

Follow-up

Difference
X

Questionnaire

SD

SD

Oswestry Disability
Questionnaire8,9

35

15b

34

15b

9b

Quebec Back Pain Disability


Scale10

41

21b

40

17b

11b

Roland-Morris Disability
Questionnaire11

Waddell Disability Index

12

SF-36 Physical Functioning


scale

4.6
51

5.2
2.3
20b

8.2
4.9
50

5.2
2.1
23b

SD

0.8
0.3
1

5.1
1.6

t Test
P

Initial

Follow-up

Difference
X

SD

SD

.38

35

17b

19

14b

.54

38

21b

20

16

.30
.31

9.5
4.4

5.9
2.2

3.8
2.6

4.1
2.1

SD

t Test
P

16

18

.000

18

22

.000

5.7
1.9

.000
b

2.5

.000

13b

.77

52

25b

70

21b

18

24b

.000

SF-36 Role Limitations


Physical scale

20

32

22

33

36

.76

19

31

57

42

39

47

.000

SF-36 Bodily Pain scale

32

17b

40

19

20b

.006

35

24

61

21b

26

28b

.000

SF-36Medical Outcomes Study 36-Item Short-Form Health Survey.13,14 For SF-36, a negative change score indicates improvement due to reverse scoring
direction. All questionnaires have a possible score range of 0 100, except for the Roland-Morris Disability Questionnaire (0 24) and the Waddell Disability Index
(0 9).
b
K-S Lilliefors confirms normal distribution of scores.

for the subgroup classified as about the same. The 15%


criterion limit was met for the Oswestry questionnaire
and the SF-36 Physical Functioning scale in both cases
and for the Quebec questionnaire when the MDC for
the subgroup was calculated. The SF-36 Role Limitations
Physical and Bodily Pain scales would be unable to detect
worsening over time in 87% and 54% of the subjects,
respectively.
Table 7 shows the point estimates and 95% CIs for the 3
methods of quantifying responsiveness. The 95% confidence intervals that are presented in Table 7 indicate
that there are no differences in the estimate of the mean
SRM across instruments. The mother used by Liang et
al37 for comparing SRMs does not use independent t
tests but rather uses paired t tests to compare multiple
SRMs for each test assembled under jackknife procedures. Using this method, the SRM of the Waddell
questionnaire was different from that of the SF-36 Bodily
Pain scale (t(105)2.92, P.004) and the Roland-Morris
questionnaire (t(105)2.52, P.013). However, if Bonferroni adjustments are made for all 21 paired comparisons, none of the effects are significant. There were no
differences among the questionnaires on the ROC
curves, as indicated by the overlap of all of the 95% CIs
and the chi-square analysis of the highest and lowest
values (Oswestry questionnaire and SF-36 Role LimitationsPhysical and Bodily Pain scales). The reliablechange method based on the MDC for the group
originally classified as unchanged and for the subgroup of 16 subjects showed no differences among the
questionnaires, with overlap of all of the 95% CIs. That
16 . Davidson and Keating

is, the proportion of subjects who changed by at least as


much as the MDC was not different among the
questionnaires.
Discussion
We chose to explore the test-retest reliability of measurements obtained for 5 questionnaires by identifying post
hoc a group of subjects who were unchanged (ie, subjects
who rated themselves as about the same, a little
better, or a little worse). We checked the validity of
measurements obtained using this strategy in 3 ways.
First, we examined the mean change scores for each
level of the global rating scale. The pattern confirmed to
us the direction and magnitude of mean change scores
for the 7 levels of the global change scale that we
expected. Only 5 subjects reported any overall worsening of their condition. There were some inconsistencies.
For example, on the SF-36 Role LimitationsPhysical
scale, the 3 subjects who rated their problem as a little
worse had an average worsening of 17 points, whereas
the 2 subjects who rated themselves as much worse
improved by an average of 13 points. These inconsistencies were likely due to the very small numbers of subjects
who selected either category; to the structure of the
SF-36 Role LimitationsPhysical scale, which yields only
5 total scores; and to the forced choice between the
ratings a little worse and much worse.
Second, we confirmed that, with the exception of the
SF-36 Bodily Pain scale, the questionnaire scores of the
subjects classified as unchanged were not different
initially and at follow-up, nor were the scores for subjects
Physical Therapy . Volume 82 . Number 1 . January 2002


SF-36Medical Outcomes Study 36-Item Short-Form Health
SEMSD (1-R), where SD is the average standard deviation for pretest and posttest for 106 subjects and R is the ICC (2,1). The MDC is
expressed in the same scale units as the questionnaires and is the 90% confidence interval of the error associated with repeated measurements.

33 (2248)
20 (1320)
14 (921)
.59 (.15.83)
41 (3350)
25 (2030)
18 (1421.5)

Survey.13,14

.37 (.09.59)
SF-36 Bodily Pain scale

Because on one of the scales (ie, the SF-36 Bodily Pain


scale) there was a difference in the unchanged group
between the initial score and the follow-up score, we also
calculated ICCs on questionnaire scores for the subgroup of 16 subjects who rated themselves as about the
same.
For the modified Oswestry Disability Questionnaire, the
ICC value of .84 (95% CI.73-.91) that we found is
comparable to the reliability coefficient reported by
Baker et al9 for same-day administration of this questionnaire (r .89). The MDC derived from the group classified as unchanged was about the same (15 points) as
the estimate of 16 points that we made from data
published by Fairbank et al8 for the original version of
the Oswestry questionnaire. The ICC for the subgroup of
16 subjects was .92 (95% CI.79-.97), and the MDC
based on this ICC value was 10.5. Applying either MDC
to the initial questionnaire scores demonstrates that the
modified Oswestry questionnaire has sufficient scale
width for clinical application of the questionnaire in this
sample. We did not find the low data quality (blank and
multiple responses) reported by Stratford and colleagues,21 and the scoring algorithm accommodates
those individuals who choose not to complete the sex life
section. We believe that the modified Oswestry questionnaire has sufficient reliability to recommend it as a
standardized measure of activity limitation. Our data
indicate that the MDC for the modified Oswestry questionnaire is either 10.5 or 15 points. Therefore, a therapist would need to see a change of at least 10.5 points
(and possibly as much as 15 points), in our opinion, to
be 90% confident that real change had occurred.
For the Quebec Back Pain Disability Scale, the ICC value
of .84 (95% CI.73.91) that we found was a little lower
than the ICC of .93 reported by Kopec et al.10 We believe
that this difference reflects either sampling differences
or the greater variability in scores we would expect
because we used a longer retest period. The MDC of 19
for the unchanged group was somewhat larger than

62 (4086)
38 (2452)
.47 (.02.78)

16 (927)
10 (616)
7 (412)

27 (1737)

.91 (.76.97)
22 (1729)

66 (5380)
40 (3249)

14 (10.518)

.39 (.11.61)
SF-36 Role LimitationsPhysical scale

28 (2335)

.83 (.71.90)
SF-36 Physical Functioning scale

10 (713)

9.5 (6.313)

2.5 (1.53.8)

5.8 (3.87.9)

1.5 (0.92.3)

4.1 (2.75.6)

1.1 (0.71.6)

.42 (.07.75)

.79 (.51.92)
2.8 (2.13.5)

8.6 (6.710.6)
5.2 (4.16.4)

1.7 (1.32.2)
1.2 (0.91.5)

3.7 (2.94.6)

.74 (.58.85)

.53 (.29.71)
Roland-Morris Disability Questionnaire

11

Waddell Disability Index12

15 (924)
9 (615)
7 (411)

10.5 (617)
6 (410)
4.5 (37)

.89 (.72.96)

15 (1119)
9 (712)

8 (610)
.84 (.73.91)
Quebec Back Pain Disability Scale10

6 (58)
.84 (.73.91)
Oswestry Disability Questionnaire8,9

11 (8.515)

19 (1424)

.92 (.79.97)

MDC
(95% CI)
SEMrepeat
(95% CI)
SEM
(95% CI)
ICC
(95% CI)
SEM
(95% CI)
ICC
(95% CI)
Questionnaire

SEMrepeat
(95% CI)

MDC
(95% CI)

Subjects Self-Rated as About the Same (n16)


Subjects Classified as Unchanged (n47)

Test-Retest Reliability (Intraclass Correlation Coefficients [ICC (2,1)]), Standard Error of Measurement (SEM), Standard Error of Repeated Measurement (SEMrepeat), and Minimum Detectable
Change (MDC) for Subjects Classified as Unchanged and Subjects Self-Rated as About the Samea

Table 5.

who rated themselves as a little better different at the


6-week follow-up. There was a difference in the SF-36
Bodily Pain scale scores between the initial and follow-up
tests (5 points for the 47 subjects classified as
unchanged and 12 points for the 16 subjects who rated
themselves as a little better), but neither magnitude of
change may be clinically meaningful. Third, we identified another group of subjects, those with back pain of
more than 6 months duration, who a priori could be
expected to experience little change over a 6-week retest
period. Intraclass correlation coefficients for this group
of 37 subjects were identical or similar to those for the
group that was classified as unchanged using the global
change scale.

Physical Therapy . Volume 82 . Number 1 . January 2002

Davidson and Keating . 17

Table 6.

Scale Width of Questionnaires at Initial Measurementa


Subjects Classified as
Unchanged (n47)b

Subjects Classified as
About the Same (n16)c

Questionnaire

Proportion of
Subjects With
Insufficient Initial
Score to
Reliably Detect
Improvement
(n140)

Proportion of
Subjects With
Insufficient Initial
Score to
Reliably Detect
Improvement
(n140)

Oswestry Disability Questionnaire8,9

11%

0%

3%

0%

Quebec Back Pain Disability Scale10

19%

4%

14%

1%

Roland-Morris Disability Questionnaire

51%

16%

51%

16%

Waddell Disability Index12

21%

20%

21%

20%

11

Proportion of
Subjects With
Insufficient Initial
Score to
Reliably Detect
Deterioration
(n140)

Proportion of
Subjects With
Insufficient Initial
Score to
Reliably Detect
Deterioration
(n140)

SF-36 Physical Functioning scale

13%

15%

9%

10%

SF-36 Role LimitationsPhysical scale

21%

87%

21%

86%

SF-36 Bodily Pain scale

11%

54%

6%

54%

SF-36Medical Outcomes Study 36-Item Short-Form Health Survey.13,14


Subjects who self-rated their condition as about the same or a little better/worse and who were classified as unchanged.
c
Subjects who self-rated their condition as about the same after 6 weeks.
b

Table 7.
Standardized Response Means (SRM), Receiver Operating Characteristic (ROC) Curves, and the Proportion of the Sample Improved at Least as
Much as the Minimum Detectable Change (MDC)a
Proportion Improved > MDC (n106)

95% CI

Based on
Subjects
Classified as
About the
Same
(n16)c

95% CI

Questionnaire

SRM
(n106)

95% CI

ROC
(n99)

95% CI

Based on
Subjects
Classified as
Unchanged
(n47)b

Oswestry Disability
Questionnaire8,9

0.52

0.511.56

.78

.69.87

24%

1633

30%

2139

Quebec Back Pain


Disability Scale10

0.49

0.471.44

.74

.64.84

23%

1531

29%

2038

Roland-Morris Disability
Questionnaire11

0.55

0.541.64

.77

.68.87

22%

1430

17%

1024

Waddell Disability
Index12

0.35

0.331.01

.76

.67.86

21%

1329

21%

1329

SF-36 Physical
Functioning scale

0.44

0.441.34

.74

.64.84

20%

1228

27%

1836

SF-36 Role Limitations


Physical scale

0.45

0.471.43

.73

.64.83

21%

1329

21%

1329

SF-36 Bodily Pain scale

0.67

0.662.00

.73

.63.84

18%

1125

23%

1531

SF-36Medical Outcomes Study 36-Item Short-Form Health Survey.13,14 95% CI95% confidence interval.
Subjects who self-rated their condition as about the same or a little better/worse and who were classified as unchanged.
c
Subjects who self-rated their condition as about the same after 6 weeks.
b

the estimate of 14 points that we calculated from Kopec


and colleagues data.10 Subjects in the study by Kopec et
al, however, were classified as unchanged if they rated
themselves as the same on a 3-level transitional scale
(better, the same, worse); therefore, the MDC of 15
18 . Davidson and Keating

points derived from the reliability data of the subjects


who said they were about the same in our study is
comparable. A change of at least 15 points in the Quebec
questionnaire score of an individual patient (and possibly as much as 19 points) would be necessary, in our
Physical Therapy . Volume 82 . Number 1 . January 2002

view, to be 90% confident that real change had


occurred. Scale width for the Quebec questionnaire
when based on the MDC for the unchanged group was
a little over the 15% criterion limit at the lower end of
the scale, with 19% of subjects having an initial score too
low to allow improvement to be detected. When based
on the MDC for the subgroup, scale width was within the
15% criterion.
For the Roland-Morris Disability Questionnaire, the ICC
value of .53 (95% CI.29 .71) that we found was
markedly lower than that reported over a 3- to 6-week
retest period by Stratford and colleagues.25 They
reported an ICC of .86 (95% CI.72.94) and an MDC
of 4 to 5 points.21 The ICC appeared lower again
(ICC.42, 95% CI .07.75) for the subgroup of 16
subjects who rated themselves as about the same, and
the lower bound of the 95% CI crosses zero. Our data
showed an MDC of 8.6 or 9.5 points based on the
reliability estimates for the 2 groups. The difference in
test-retest reliability found in other studies and in our
study may be explained by sample differences. The
subjects in the studies by Stratford and colleagues17,25
were referred by physicians to the physical therapy
outpatient department of 1 or 2 hospitals. In contrast, we
drew our sample from a range of physical therapy
outpatient services, and we believe that our subjects were
more likely to be more variable and more closely representative of the general clinical population in a health
care system where patients may consult a physical therapist with or without referral from a physician.
The sample in our study included a greater proportion
of female subjects, were on average older, had lower
initial Roland-Morris questionnaire scores, and had a
longer duration of back pain than the samples in the
studies by Stratford and colleagues.17,25 If sample differences were sufficient to explain poorer test-retest reliability for the Roland-Morris questionnaire, we would
expect to have seen a similar effect with the other
questionnaires, but this was not the case. The use of the
average of the patients and the therapists ratings of
overall change in the studies by Stratford and colleagues
may have screened out the types of subjects in our study
who showed considerable variability in scores. Subjects
in our study who reported no change but whose RolandMorris questionnaire scores suggested they had
changed, tended to have had their low back problem for
more than 6 months. Perhaps these subjects had become
used to their problem and reported no overall perception of change, despite the functional improvement
detected by the Roland-Morris questionnaire. This
explanation, however, seems unlikely in the absence of
similar variability in the scores of the other questionnaires. Another possibility is that the variability in scores
may reflect the emphasis in the Roland-Morris question-

Physical Therapy . Volume 82 . Number 1 . January 2002

naires instructions to subjects to select an item only if


you are sure that it describes you today. Low back pain
can vary considerably from day to day; thus, RolandMorris questionnaire scores will reflect diurnal variations
in activity limitations. The instructions also urge that if
the sentence does not describe you, then leave the space
blank; therefore, it is possible that subjects will not
select an item if they have not attempted that activity that
day.
The poor reliability and consequently large MDC for the
Roland-Morris questionnaire severely reduces the scale
width. At the time of the initial measurements, 51% of
the subjects scored less than the MDC. Therefore, the
Roland-Morris questionnaire would not be able to reliably detect improvement in half of the sample. Even
using the previous best estimate by Stratford et al17 of the
MDC at scale extremes of 4 points, 19% of the subjects
scored less than 4 points at initial testing. On the basis of
the poor test-retest reliability and consequently large
MDC and limited scale width, we cannot recommend the
use of the Roland-Morris questionnaire as a measure of
functional outcome in a general clinical population.
The test-retest reliability of measurements obtained with
the Waddell Disability Index has not previously been
reported for a self-administered version of the questionnaire. We calculated the ICCs as .74 (95% CI.58 .85)
for the unchanged group and .79 (95% CI.51.92)
for the subgroup and the MDC as around 3 points,
which constitutes one third of the available range of the
scale. The potential clinical utility of the Waddell Disability Index is diminished by the relatively large MDC
and a lack of scale width, as 21% of the sample scored
less than 3 points and 20% more than 6 points at the
initial measurement.
The ICCs of .83 (95% CI.71.90) and .91 (95%
CI.76 .97) that we obtained for the SF-36 Physical
Functioning scale are similar to that reported by Patrick
et al22 (ICC.89), who analyzed the data for 52 subjects
with sciatica who self-rated their leg pain as unchanged
over a 3-month retest period. The MDC of 22 is close to
the 21 points we estimated from the data reported by
Patrick et al. When based on the smaller subgroup in our
study, the MDC might be as low as 16. Scale width is
within the 15% criterion limit whether the MDC of 16 or
22 is applied, and the SF-36 Physical Functioning scale
therefore appears to be an appropriate scale for use by
physical therapists. A therapist would need to observe a
change in the SF-36 Physical Functioning scale score of
at least 16 points (or 22 points by the less stringent
reliability analysis) to be 90% confident that real change
had occurred.

Davidson and Keating . 19

The ICCs for the Role LimitationsPhysical and Bodily


Pain scales of the SF-36 in our study were considerably
lower than those reported by Patrick et al22 (ICC.80
and .67). Although the ICCs for the subgroup who rated
themselves as about the same were somewhat stronger,
they were still weak (ICC.47 and .59), and the lower
bound of the CIs approached zero. In the study by
Patrick et al, subjects rated the overall change in their
leg pain rather than the change in their overall condition. In addition, the subjects had sciatica secondary to a
herniated lumbar intervertebral disk and represent a
different clinical population than the subjects in our
study. The different results, therefore, may relate to
differences in sample characteristics (eg, variance differences), but scale characteristics may also help explain
the different results. The SF-36 Role Limitations
Physical scale consists of 4 questions with forced-choice
(yes/no) responses, and available total scores are therefore 0, 25, 50, 75, and 100. For any individual, a small
number of changes in responses from yes to no or
vice versa could have a very large effect on the score.
Score distribution was very skewed, with 66% of the
subjects at the initial measurement and 42% of the
subjects at the follow-up measurement scoring 0, the
worst possible score. Thirty subjects scored 0, the worst
possible score, at both pretest and posttest, but many
others showed large improvements and worsening. The
data for the SF-36 Role LimitationsPhysical scale were
highly skewed, and the estimate of MDC of 62 or 66
points is likely to be overestimated.
There was a small improvement in SF-36 Bodily Pain
scale scores over the retest period for subjects classified
as unchanged and for those who rated their back
condition as a little better. The SF-36 Bodily Pain scale
has only 2 items, and poor reliability is more likely in
very brief scales. The MDC was 33 or 41 points, and scale
width was beyond the 15% criterion limit at the lower
end of the scale range. On its own, the SF-36 Bodily Pain
scale, in our view, cannot be said to be an adequate
measure of pain or pain-related function, comprised as it
is of one pain intensity item and one item regarding how
much pain interferes with normal work. Because of the
substantial floor effect, the poor scale width, and the
variability in scores in stable subjects, the SF-36 Role
LimitationsPhysical and Bodily Pain scales do not
appear to be useful measures of functional outcome for
individual patients.
Based on these data, the Physical Functioning scale is the
most relevant of the SF-36 physical health scales, and it
can be easily hand-scored. We see advantages, however,
in administering the SF-36 in its entirety. The SF-36
provides a health status profile, rather than a single
index score, and individual and aggregated data can be
compared with the population norms available in many

20 . Davidson and Keating

countries.15,16,41 45 The International Quality of Life


Assessment (IQOLA) Project is translating, validating,
and norming the SF-36 in 14 countries: Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan,
the Netherlands, Norway, Spain, Sweden, the United
Kingdom (English version), and the United States
(English and Spanish versions).46 The scales in the
mental health domain may provide a brief screening tool
to alert the clinician to the need for appropriate referral.
The main disadvantage of the SF-36 is that hand-scoring
of some of the 8 scales is laborious, in our view, because
of the complex scoring algorithm. However, SF-36 scores
can be easily generated using a spreadsheet, and customized scoring software is also available.
The results of the reliability portion of our study indicated that the modified Oswestry Disability Questionnaire, the SF-36 Physical Functioning scale, and the
Quebec Low Back Disability Scale were the most reliable
and had sufficient scale width to detect improvement or
worsening in most subjects. The reliability of measurements obtained with the Waddell Disability Index is
moderate, but we believe the scale width is insufficient to
recommend it for clinical application. The RolandMorris Disability Questionnaire and the SF-36 Role
LimitationsPhysical and Bodily Pain scales lacked sufficient reliability and scale width for clinical application.
Test-retest reliability results for the Roland-Morris Disability Questionnaire differed from those of earlier
reports, and this highlights the importance of examining
reliability in the population to which the measurement
tool will be applied in practice.
In the second part of our study, we explored the
responsiveness of the 5 questionnaires. Just as measurements obtained with a test may be reliable but not valid,
it is possible for a test to yield reliable measurements but
to be unresponsive. There has also been some debate
about whether a test can yield unreliable measurements
yet be responsive.47,48 There is currently no agreement as
to the most appropriate method of evaluating the
responsiveness of tests.24,27,49,50 Therefore, we explored
responsiveness using 3 methods by which point estimates
and 95% CIs could be calculated and the differences
among questionnaires tested. The SRM is typical of the
distribution-based or overall-change approach, and the
ROC curve is representative of the criterion-based or
valid-change approach. The third method, which calculates the proportion of subjects who change by at least as
much as the MDC has not previously been used and can
be termed a reliable-change approach.
The absolute value of the SRM can be interpreted in the
same way was an effect size, where .20 is regarded as
small, .40 as moderate, and .80 as large.51 The SRM point
estimate values for the questionnaires in our study were

Physical Therapy . Volume 82 . Number 1 . January 2002

moderate, and the 95% CIs were very wide. We chose the
SRM because it is the only distribution-based method for
which a method of hypothesis testing has been
described.27,37 We believe there is considerable opportunity in the repeated iterations of Liang and colleagues
complex SRM procedure37 for error. The jackknife
procedure used to generate what Liang and colleagues
called pseudo-values37 is performed by systematically
dropping each subjects data from analysis at a time.
That is, the SRM is recalculated n times with each subject
removed in turn. This results in a population of n SRM
pseudo-values around the sample SRM and provides a
sampling distribution of SRMs from which to estimate a
population SRM. The population SRM and variance are
then estimated from the pseudo-values, and finally a t
test is used to compare the tests. We found that the result
was distorted unless calculations were made to 5 decimal
places.
The area under the ROC curve has a possible range from
.50, indicating a chance finding, to 1.0, indicating perfect ability of change scores to discriminate between
changed and unchanged patients. The ROC point estimate in our study fell within a narrow range from .73 to
.78, and there was no difference among the scores from
the questionnaires, suggesting that all of the tests were
equivalent in responsiveness. The ROC values of .78 and
.77 that we obtained for the Oswestry and Roland-Morris
questionnaires are almost identical to those reported by
Stratford and colleagues21 (.78 and .79). Beurskens et
al20 reported a similar ROC value for the Oswestry
questionnaire (.76), but a higher value for the RolandMorris questionnaire (.93).
Criterion-based methods require the sample to be
dichotomized into those subjects who are unchanged
and those who have improved by a certain amount.27,28
The use of patients self-ratings of overall change as the
criterion of meaningful clinical change has several limitations: the measurements have unknown reliability and
validity; recall of initial states tend to be inflated, which
tends to inflate the perceived magnitude of change; and
the scale is completed at the same time as the follow-up
questionnaires and is therefore not independent.52 In
our study, subjects were asked to complete the rating of
change scale before the questionnaires, and the completion of the questionnaires may have been influenced by
the overall rating. However, because the questionnaires
were administered by mail, we have no way of knowing
the order in which the subjects completed the tasks.
Patient self-ratings, or averages of patient and therapist
ratings of overall change, are commonly used as the
criterion of change because of the valued perspective of
the rater(s) and because the information can be collected easily.

Physical Therapy . Volume 82 . Number 1 . January 2002

The reliable-change method of evaluating responsiveness counted the number of subjects who changed by at
least as much as the MDC over 6 weeks. Because we had
performed 2 reliability analyses, one for the group
classified as unchanged and one for the smaller subgroup who had rated themselves as about the same, we
had 2 estimates of MDC. In neither case was the proportion different among the questionnaires.
In the responsiveness portion of our study, we found that
none of the questionnaires could be shown to be more
or less responsive than any other. Furthermore, it
appears possible for a questionnaire to yield scores with
very poor reliability, but to have reasonable responsiveness. The SF-36 Bodily Pain scales ICC was lower than
.50, but the scale was comparable in responsiveness to
the other questionnaires. This finding may indicate
either that the questionnaires perform similarly in their
ability to detect change over time or that the responsiveness methods are not able to discriminate between
instruments with low and high responsiveness. The
proliferation of responsiveness measures and debate
concerning methods for determining responsiveness
suggest that the optimal way to quantify this relatively
recently conceptualized psychometric property of tests
has not been described.27,28,48,50 The validity of scores
obtained with a responsiveness index could be demonstrated by testing whether the index is able to discriminate between a test that is known to be responsive and
one that is known not to detect change over time in a
particular clinical population.
We suggest that the choice of a responsiveness index
should be dictated by the purpose for which the index is
being used in this application. If the aim is to quantify
the responsiveness of an outcome measure to be used in
research, then we believe that a distribution-based
method would be most appropriate, as this information
could be used to estimate sample size and statistical
power. Distribution-based methods, however, provide no
information about whether change is clinically meaningful. A criterion-based method may be appropriate where
the purpose is to detect meaningful change in a clinical
setting. Distribution-based methods provide information
analogous to a test of statistical significance, and
criterion-based methods are analogous to a judgment of
clinical significance. The reliable-change method, in our
opinion, provides practical information for clinical
application in that it answers the question, In what
proportion of my patients is this questionnaire likely to
detect change beyond the amount that can be attributed
to measurement error? The limitation of this method is
that the MDC may not be known for many questionnaires and clinical tests.

Davidson and Keating . 21

We are the first authors to report on reliability and


responsiveness for these 5 questionnaires in a sample
drawn from the range of settings in which patients with
low back pain seek physical therapy interventions. Our
sample was drawn from hospitals, private practices, and
community-based services, whereas previous studies have
used samples obtained from patients seeking physical
therapy at 1 or 2 hospitals or practices17,18,25 or from
both physical therapy and medical treatment centers.10
Although our sampling strategy was designed to obtain a
representative sample, a number of factors tend to
reduce generalizability. The success of consecutive sampling may have been obscured if therapists did not
record instances when they failed to approach a potential subject. Only 7 such instances were recorded, and it
is possible that underreporting occurred in the course of
busy daily practice and due to the eagerness of the
therapist to appear cooperative. In addition, 67 subjects
(32%) who initially agreed to participate failed to return
the first set of questionnaires, and it is not known
whether this group was different from those who actually
participated in the study. In addition, because the
recruitment sites were all located in urban areas, the
sample may not reflect differences in the profile of
clients seeking physical therapy in rural locations. For
practical reasons, people who could not read or write
English were excluded, and the results therefore may
not be generalizable to people from nonEnglishspeaking backgrounds.
Another limitation of our study is the use of the global
rating of change scale as the sole criterion of meaningful
change. Whether the single-item global change scale
used in this study yields reliable measurements is
unknown, and it is likely that the rating was not independent of the activity limitation questionnaire
responses. That is, a subjects response to the global
rating of change may have influenced the subsequent
responses to the questionnaires at follow-up. Norman
and colleages52 identified one study of quality of life in
childhood asthma53 where the criterion of change was
determined by an independent evaluation of all patient
data. It needs to be established whether an independent
evaluation of change based on these data would be a
better criterion of change in patients with low back
pain.52,53
In the questionnaires that we studied, subjects were
asked to report activity limitation during different time
periods (Tab. 1), which could have influenced their
responses. The Roland-Morris and Quebec questionnaires ask about activity limitation today, the SF-36
Physical Functioning scale asks about activity limitation
now, the SF-36 Role LimitationsPhysical and Bodily
Pain scales ask about activity limitation during the past

22 . Davidson and Keating

4 weeks, and the Oswestry questionnaire gives no specific time reference. We are unaware of any studies that
have explored this issue, although Fairbank and
Pynsent54 recently reported that patients prefer a format
such as that of the Oswestry questionnaire in which the
time frame now is made explicit.
A surprising result in our study was that although 49% of
the subjects said their condition was better, much
better, or completely gone after 6 weeks, none of the
questionnaires reliably detected change in more than
30% of the subjects (Tab. 7). This result illustrates that
the amount of change in questionnaire scores perceived
by the client to be meaningful may be smaller than the
amount of change required to be statistically 90% confident that score change is not just measurement error
(the MDC). More reliable and responsive methods need
to be developed for measuring activity limitation in
people with low back pain. Perhaps we are currently
overestimating the SEM (and therefore the MDC)
derived from small samples. However, the consequences
of wrongly concluding that a patient with low back pain
either has or has not changed by a measurable amount
based on change in questionnaire scores are unlikely, in
our opinion, to be substantially adverse. If a patients
status does not change by at least as much as the current
MDC within an expected time-frame, the therapist may
decide to alter some component of the treatment regimen, to refer the patient to another health care professional, or to cease therapy. The clinician faced with
interpreting a change in an individual patients questionnaire scores will advisedly use a range of outcome
indicators to provide a picture of overall change.
Although we contend that the modified Oswestry Disability Questionnaire, the SF-36 Physical Functioning
scale, and the Quebec Back Pain Disability Scale appear
to be the most useful measures of functional outcome
for people with low back pain, there are practical
considerations that also influence the choice of questionnaire. If a clinician sees few patients with low back
problems and fast processing of results is the primary
consideration, then the Waddell Disability Index may be
appropriate. Therapists in multidisciplinary clinics may
decide that the SF-36 can provide the more comprehensive assessment required for their purposes. Scale content also provides a point of differentiation. For example, the SF-36 does not ask about difficulty sustaining
body positions such as sitting and standing, and the
Oswestry questionnaire does not include difficulty moving between postures such as sit to stand. The Quebec
questionnaire has more content relating to upper-limb
activities (pulling/pushing, throwing/catching, reaching) than the other scales. Notwithstanding a careful
choice of scale, there will always be some individuals who
do not have a sufficient initial score to enable change to

Physical Therapy . Volume 82 . Number 1 . January 2002

be reliably detected over time. Clinicians, therefore,


should have alternative or multiple strategies for measuring functional outcome, and they should be aware of
the limitations of each method.
Conclusion
Our data indicate that the Oswestry Disability Questionnaire, the SF-36 Physical Functioning scale, and the
Quebec Back Pain Disability Scale have sufficient reliability and scale width to be applied in an ambulatory
clinical population with low back problems. The Waddell Disability Index has insufficient scale width for
clinical utility. The Roland-Morris Disability Questionnaire and the SF-36 Role LimitationsPhysical and
Bodily Pain scales did not have sufficient reliability to be
recommended as clinical outcome measures for individual patients. This study showed that the responsiveness
of the questionnaires was similar, and we conclude that
one questionnaire cannot be preferred over another
based on the magnitude of the absolute values of responsiveness indexes.
References
1 Beattie P, Maher C. The role of functional status questionnaires for
low back pain. Australian Journal of Physiotherapy. 1997;43:29 38.

14 McHorney CA, Ware JE Jr, Lu RJF, Sherbourne CD. The MOS


36-Item Short-Form Health Survey (SF-36), III: tests of data quality,
scaling assumptions, and reliability across diverse patient groups. Med
Care. 1994;32:40 66.
15 Ware JE Jr. SF-36 Health Survey: Manual and Interpretation Guide.
Boston, Mass: The Health Institute;1993.
16 National Health Survey: SF-36 Population Norms. Canberra, Australian
Capital Territory, Australia: Australian Bureau of Statistics; 1997.
17 Stratford PW, Binkley JM, Solomon P, et al. Defining the minimum
level of detectable change for the Roland-Morris Questionnaire. Phys
Ther. 1996;76:359 365.
18 Beurskens AJHM, de Vet HCW, Koke AJA, et al. Measuring the
functional status of patients with low back pain: assessment of the
quality of four disease-specific questionnaires. Spine. 1995;20:
10171028.
19 Binkley JM. Measurement of functional status, progress, and outcome in orthopaedic clinical practice. Ortho Div Review. September/
October 1998:717.
20 Beurskens AJHM, de Vet HCW, Koke AJA. Responsiveness of
functional status in low back pain: a comparison of different instruments. Pain. 1996;65:7176.
21 Stratford PW, Binkley JM, Solomon P, et al. Assessing change over
time in patients with low back pain. Phys Ther. 1994;74:528 533.
22 Patrick DL, Deyo RA, Atlas SJ, et al. Assessing health-related quality
of life in patients with sciatica. Spine. 1995;20:1899 1908.

2 Delitto A. Are measures of function and disability important in low


back care? Phys Ther. 1994;74:452 462.

23 Streiner DL, Norman GR. Health Measurement Scales: A Practical Guide


to Their Development and Use. 2nd ed. New York, NY: Oxford University
Press Inc; 1995.

3 ICIDH-2: International Classification of Functioning, Disability, and


HealthPrefinal Draft Full Version. Geneva, Switzerland: World Health
Organization; 2000.

24 Stucki G, Liang MH, Fossel AH, Katz JN. Relative responsiveness of


condition-specific and generic health status measures in degenerative
lumbar spinal stenosis. J Clin Epidemiol. 1995;48:1369 1378.

4 Nelson MA, Allen P, Clamp SE, de Dombal FT. Reliability and


reproducibility of clinical findings in low-back pain. Spine. 1979;4:
97101.

25 Stratford PW, Finch E, Solomon P, et al. Using the Roland-Morris


Questionnaire to make decisions about individual patients. Physiotherapy Canada. 1996;48:107110.

5 Waddell G, Main CJ, Morris EW, et al. Normality and reliability in the
clinical assessment of backache. BMJ. 1982;284:1519 1530.

26 McHorney CA, Tarlov AR. Individual-patient monitoring in clinical


practice: are available health status surveys adequate? Qual Life Res.
1995;4:293307.

6 Kopec JA. Measuring functional outcomes in persons with back pain:


a review of back-specific questionnaires. Spine. 2000;25:3110 3114.
7 Bombardier C. Outcome assessments in the evaluation of treatment
of spinal disorders. Spine. 2000;25:3110 3103.

27 Stratford PW, Binkley JM, Riddle DL. Health status measures:


strategies and analytic methods for assessing change scores. Phys Ther.
1996;76:1109 1123.

8 Fairbank JCT, Couper J, Davies JB, OBrien JP. The Oswestry Low
Back Pain Disability Questionnaire. Physiotherapy. 1980;66:271273.

28 Lydick E, Epstein RS. Interpretation of quality of life changes. Qual


Life Res. 1993;2:221226.

9 Baker DJ, Pynsent PB, Fairbank JCT. The Oswestry Disability Index
revisited: its reliability, repeatability, and validity, and a comparison
with the St Thomas Disability Index. In: Roland M, Jenner JR, eds. Back
Pain: New Approaches to Rehabilitation and Education. Manchester, United
Kingdom: Manchester University Press; 1989:174 186.

29 Fordyce WE, ed. Back Pain in the Workplace: Management of Disability


in Nonspecific Conditions. Seattle, Wash: IASP Press; 1995.

10 Kopec JA, Esdaile JM, Abrahamowicz M, et al. The Quebec Back


Pain Disability Scale: measurement properties. Spine. 1995;20:341352.

31 van den Hoogen HJM, Koes BW, van Eijk JTM, et al. On the course
of low back pain in general practice: a one year follow up study. Ann
Rheum Dis. 1998;57:1319.

11 Roland M, Morris R. A study of the natural history of back pain, part


I: development of a reliable and sensitive measure of disability in low
back pain. Spine. 1983;8:141144.
12 Waddell G, Main CJ. Assessment of severity in low-back disorders.
Spine. 1984;9:204 208.
13 Ware JE Jr, Sherbourne CD. The MOS 36-Item Short-Form Health
Survey (SF-36), 1: conceptual framework and item selection. Med Care.
1992;30:473 483.

Physical Therapy . Volume 82 . Number 1 . January 2002

30 Waddell G, Feder G, McIntosh A, et al. Low Back Pain Evidence


Review. London, United Kingdom: Royal College of General Practitioners; 1996.

32 SF-36 Health Survey Scoring Manual for English-Language Adaptations:


Australia/New Zealand, Canada, United Kingdom. Boston, Mass: Medical
Outcomes Trust; 1994.
33 Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater
reliability. Psychol Bull. 1979;86:420 428.
34 Zimmerman D. Mimicking properties of nonparametric rank tests
using scores that are not ranks. J Gen Psychol. 1993;120:509 516.

Davidson and Keating . 23

35 Jacobson NS, Follette WC, Revensdort D. Psychotherapy outcome


research: methods for reporting variability and evaluating clinical
significance. Behav Ther. 1984;15:336 352.

45 Jenkinson C, Wright L, Coulter A. Quality of Life Measurement in


Health Care: A Review of Measures and Population Norms for the UK SF-36.
Oxford, United Kingdom: Services Research Unit; 1993.

36 Christensen L, Mendoza JL. A method of assessing change in a


single subject: an alteration of the RC index [letter to the editor].
Behav Ther. 1986;17:305308.

46 The International Quality of Life Assessment (IQOLA) Project.


Available at: http://www.iqola.org.

37 Liang MH, Fossel AH, Larson MG. Comparisons of five health status
instruments for orthopedic evaluation. Med Care. 1990;28:632 642.
38 Goldie PA, Matyas TA, Evans OM. Deficit and change in gait velocity
during rehabilitation after stroke. Arch Phys Med Rehabil. 1996;77:
1074 1082.
39 Bland M. An Introduction to Medical Statistics. 2nd ed. New York, NY:
Oxford University Press; 1995.

47 Guyatt G, Walter S, Norman G. Measuring change over time:


assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;
40:171178.
48 Hays RD, Hadorn D. Responsiveness to change: an aspect of validity,
not a separate dimension. Qual Life Res. 1992;1:7375.
49 Wright JG, Young NL. A comparison of different indices of responsiveness. J Clin Epidemiol. 1997;50:239 246.

40 Coakes SJ, Steed LG. SPSS Version 6.1 Analysis Without Anguish.
Brisbane, Queensland: Australia: John Wiley & Sons; 1997.

50 Deyo RA, Diehr P, Patrick DL. Reproducibility and responsiveness


of health status measures: statistics and strategies for evaluation. Control
Clin Trials. 1991;12(suppl 4):142S158S.

41 Hopman WM, Towheed T, Anastassiades T, et al. Canadian normative data for the SF-36 health survey. CMAJ. 2000;163:265271.

51 Cohen J. Statistical Power Analysis for the Behavioral Sciences. New York,
NY: Academic Press Inc; 1977.

42 Scott KM, Tobias MI, Sarfati D, Haslett SJ. SF-36 health survey
reliability, validity and norms for New Zealand. Aust N Z J Pub Health.
1999;23:401 406.

52 Norman GR, Stratford PW, Regehr G. Methodological problems in


the retrospective computation of responsiveness to change: the lesson
of Cronbach. J Clin Epidemiol. 1997;50:869 879.

43 Aaronson NK, Muller M, Cohen PD. Translation, validation, and


norming of the Dutch language version of the SF-36 Health Survey in
community and chronic disease populations. J Clin Epidemiol. 1998;51:
10551068.

53 Juniper EF, Guyatt GH, Feeny DH, et al. Measuring quality of life in
childhood asthma. Qual Life Res. 1996;5:35 46.
54 Fairbank JCT, Pynsent PB. The Oswestry Disability Index. Spine.
2000;25:2940 2953.

44 Loge JH, Kaasa S. Short form 36 (SF-36) health survey: normative


data from the general Norwegian population. Scand J Soc Med. 1998;
26:250 258.

24 . Davidson and Keating

Physical Therapy . Volume 82 . Number 1 . January 2002

Das könnte Ihnen auch gefallen